Our Framework

75% of MedTech Startups Fail.
Most of Those Risks Are Knowable — Before You Commit.

Our proprietary framework identifies the clinical, regulatory, and commercial risks that standard due diligence misses — before capital is deployed.

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Multi-Domain

Proprietary assessment framework

MD + BME

Physician & engineer-led review

Calibrated

Against documented outcomes

a few business days

Typical assessment timeline

How It Works

From Submission to Strategic Insight

Your assessment moves through six integrated stages — each combining physician expertise with engineering rigor.

Step 1 of 6
Submit
Upload your materials
Clinical Review
Physician analysis
Technical Review
Engineering analysis
Pattern Match
proprietary database
Risk Scoring
Proprietary Vantage Score
Report Delivery
Actionable intelligence
01
Secure Document Upload
You provide company materials through our encrypted portal. We handle the rest. Typical uploads include pitch deck, regulatory filings, clinical data, financial projections, and competitive analysis.
Pitch deck & investor materials
FDA submissions & regulatory files
Clinical trial data & publications
Financial projections & cap table
Patent portfolio & IP filings
Manufacturing & quality docs
02
Physician Clinical Analysis
Our physician reviews from the clinical lens — the perspective VCs and consultants cannot replicate. This catches the adoption barriers that kill 75% of medical device startups.
Clinical adoption feasibility
Evidence & outcomes evaluation
Safety profile assessment
Competitive landscape analysis
03
Biomedical Engineering Review
Our BME assesses technical feasibility, manufacturing scalability, regulatory pathway, and IP strength — the engineering depth that separates real risk from surface-level DD.
Regulatory pathway assessment
Manufacturing & scalability review
IP strength evaluation
Design & quality analysis
04
Outcome Benchmarking
Your company's risk profile is benchmarked against our proprietary database of documented life science outcomes — surfacing risks that standard due diligence cannot detect.
Extensive outcome database spanning multiple verticals
Grounded in a multi-source public-data substrate (FDA, SEC, ClinicalTrials.gov, USPTO, CMS)
Every figure traceable to its public source — independently verifiable
Benchmarked against documented historical outcomes
Continuously refined with every new engagement
05
Proprietary Vantage Score
Each assessment produces a composite Vantage Score — a single, calibrated metric that synthesizes risk across all proprietary assessment dimensions. The score distinguishes between risks that require immediate intervention and those manageable with the right roadmap.
Composite score calibrated against extensive documented outcomes
Actionable risk classification across all assessment domains
Prioritized remediation roadmap with timeline
Clear distinction between deal-breakers and fixable gaps
Stage-appropriate evaluation from seed to growth
06
Your Deliverable
A comprehensive report with executive summary, full proprietary scoring, risk analysis with historical precedents, remediation roadmap, and a 1-hour findings call with your team.
Executive Summary
Scoring Matrix
Remediation Plan
a few business days

The 20-Category Assessment Framework

Every engagement is evaluated across four strategic domains and twenty standardized risk categories, refined through analysis of 800+ outcome-labeled biomedical companies in our proprietary cohort substrate and growing with every engagement. We publish the category structure below; the specific scoring criteria and weights remain proprietary.

Clinical & Regulatory

  • · Regulatory pathway viability
  • · Clinical evidence quality
  • · Safety signal assessment
  • · Unmet need alignment
  • · Clinical data maturity
Physician-led review

Technical & IP

  • · IP strength assessment
  • · Technical differentiation
  • · Manufacturing readiness
  • · Supply chain resilience
  • · Quality systems maturity
Engineering-led review

Commercial

  • · Market sizing accuracy
  • · Competitive positioning
  • · Reimbursement pathway
  • · Pricing & market access
  • · Channel distribution
Market & access analysis

Organizational

  • · Management team depth
  • · Financial health
  • · Team completeness
  • · Board & advisor strength
  • · Fundraising trajectory
Team & financial review

The specific evaluation criteria, sub-signals, and scoring weights behind each category are proprietary — refined through analysis of documented device outcomes and tailored by stage, device class, and intended market.

We share the full framework under NDA during discovery calls so you can evaluate our approach before engaging. Request a methodology briefing →

What Sets Us Apart

Beyond Standard Due Diligence

Proprietary Scoring

Every assessment domain receives a proprietary Vantage Score with detailed justification. Our scoring system distinguishes between risks that require immediate intervention and those that are manageable with appropriate resources and timeline. The composite Vantage Score gives you a single, calibrated number backed by domain-level detail.

Critical Risk Identification

Our framework distinguishes between risks that can be mitigated through execution and those that represent fundamental barriers — so you know exactly where to invest and where to walk away.

Multi-Domain Proprietary Assessment

Our proprietary analysis combines physician and biomedical engineering domain expertise with an extensive database of documented life science outcomes. Each submission is evaluated across multiple strategic domains using proprietary risk categories calibrated against real-world successes and failures.

Clinical & Regulatory

Will physicians adopt it? Will regulators approve it? Will payers cover it? We assess the clinical and regulatory risks that traditional DD misses entirely.

Technical & IP

Can it be manufactured at scale? Is the IP defensible? We evaluate engineering maturity, IP landscape, and technical risk from a biomedical engineering lens.

Commercial

Do the market assumptions hold under clinical reality? We stress-test commercial viability against real-world adoption patterns, not pitch deck projections.

Organizational

Does the team have the depth to execute? We assess organizational readiness, leadership gaps, and financial trajectory against stage-appropriate benchmarks.

Proprietary scoring calibrated against an extensive database of documented life science outcomes, validated through cross-validation against clinical and commercial results.

Your Assessment Team

The MD + BME Partnership

Every engagement is led by our co-founders — a physician and biomedical engineer who review your assessment personally.

Dr. Arvind Ravinutala

Arvind Ravinutala, MD

Chief Medical Officer

Practicing physician & Medical Director. Chairs P&T Committee evaluating device adoption. Clinical Informatics & Bioethics.

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Aswini Ravinutala

Aswini Ravinutala, BME

Chief Technology Officer

Biomedical engineer, ex-Axonics (through Boston Scientific's $4.1B acquisition). Assesses manufacturing, quality systems & engineering depth.

Connect

Supported by Senior Advisor Rinda Sama (former COO, Axonics) and a specialist network spanning 8 life science verticals. Meet the full team →

Ready to Get a Vantage Assessment?

In a few business days, you'll have a comprehensive risk report and a clear roadmap for your next steps.

Schedule Discovery Call Free 20-Min Call

Not sure if you need an assessment? In a free 20-minute call, we'll identify the 3 biggest risks in your device category.

† Based on retrospective analysis of documented device outcomes across 800+ outcome-labeled biomedical companies in our proprietary cohort substrate, growing with every engagement. Cohort-anchored differentiator analysis with effect-size disclosure across our proprietary benchmark dataset.

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